Moultrie Rebecca R, Henderson Gail, Potter Sarah Nelson, Cheves Emily, Kuczynski Kristine J, Jackman Dean, Rennie Stuart, Gay Cynthia, Gieck Chelsea, Chisholm Yujiemi, Peay Holly L
Center for Communication and Engagement Research, Center for Communication Science, RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, 27709, Research Triangle Park, NC, USA.
School of Medicine, Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
AIDS Behav. 2025 Jun 10. doi: 10.1007/s10461-025-04764-1.
HIV remission (or cure) clinical trials require potential participants to understand trial-related risks, approaches to minimize risks, potential benefits, procedures, and participation alternatives to make an informed decision. Decision aids (DAs) support preference-sensitive decisions. We report on the development and evaluation of a DA called Decision Partner, designed to support informed consent. We used an iterative, mixed-methods approach to develop and test Decision Partner. We conducted research and engagement activities among people living with HIV (PLWHIV), advocates, researchers, trialists, and clinicians which resulted in a product reflective of information required for informed choice. Among 20 PLWHIV, 90% rated that Decision Partner would be useful for decision-making. Decision conflict significantly decreased after using Decision Partner (37.3 to 16.8, p =.007) and knowledge significantly increased from pre to-post(z = -3.11, p <.01). Our findings indicated that Decision Partner holds promise to augment the informed consent process, in HIV remission trials.
艾滋病病毒缓解（或治愈）临床试验要求潜在参与者了解与试验相关的风险、降低风险的方法、潜在益处、程序以及参与替代方案，以便做出明智的决定。决策辅助工具（DAs）有助于做出偏好敏感型决策。我们报告了一种名为“决策伙伴”的决策辅助工具的开发与评估情况，该工具旨在支持知情同意。我们采用迭代式混合方法来开发和测试“决策伙伴”。我们在艾滋病病毒感染者（PLWHIV）、倡导者、研究人员、试验人员和临床医生中开展了研究和参与活动，最终形成了一个反映知情选择所需信息的产品。在20名艾滋病病毒感染者中，90%的人认为“决策伙伴”对决策有用。使用“决策伙伴”后，决策冲突显著降低（从37.3降至16.8，p = 0.007），知识水平从使用前到使用后显著提高（z = -3.11，p < 0.01）。我们的研究结果表明，“决策伙伴”有望在艾滋病病毒缓解试验中增强知情同意过程。
